Institute of Medical Biology,Chinese Academy of Medical Sciences

The First Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell) All Over the World

After 8 year’s efficient work, EntroVac® , the first vaccine against Hand, Foot and Mouth Disease (HFMD) caused by Enterovirus Type 71 (EV-71) was approved by CFDA in 3rd December, 2015.

Development milestone:

In 2007, Laboratory research was started.

In 2008, a viral strain was isolated in Fuyang, Anhui province, China.

In 2010, the approval to conduct clinical trials was obtained.

In 2013, clinical trials were finished.

In 2015.12.3, approval certificate of EntroVac® was released by CFDA.

In 2016.3.18, EntroVac® was launched to market.

In 2016.3.22, the first dose was immunized.

The Innovative Vaccine from Theory to Practice

Utilizing domestic primate resources, IMBCAMS invented neonatal monkey model to extract pathological features of EV-71 infection and to evaluate protective effect of EntroVac®.

Immune response mechanism induced by EntroVac® was analyzed in clinical trials.

A multi-center phase III clinical trial involving 12000 subjects at 6 to 71 months age sufficiently proved the safety and efficacy of the product. Over two course of epidemic seasons, efficacy of the vaccine was 97.3%. 

The Persistent Research Provides the World Powerful Weapons in Controlling HFMD

EntroVac® created by IMBCAMS is derived from the C4 subtype of EV-71, but the cross-neutralization test suggested that the vaccine could protect against most circulating EV-71 strains in different countries.

At present, scientists in IMBCAMS are still pushing forward the research on other major pathogens of HFMD such as Coxsackie virus A16. In future, the prospective research of combined vaccines containing different Enteroviruses will provide a stronger strategy in preventing HFMD.